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VP of Discovery & Translational Research

ExecuNet San Francisco Full-Time
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Company is the leader in prescription digital therapeutics. We aim to redefine medicine by discovering, developing, and delivering clinically validated software-based therapeutics to provide better outcomes for patients, smarter engagement and tracking tools for clinicians, and cost-effective solutions for payers. Pear has a pipeline of products and product candidates across therapeutic areas, including severe psychiatric and neurological conditions. Our lead product, reSET®, treats Substance Use Disorder and was the first prescription digital therapeutic to receive marketing authorization from the FDA to treat disease. Pear’s second product, reSET-O™, for the treatment of Opioid Use Disorder, received marketing clearance from the FDA in December 2018.

Description:

The Vice President of Discovery and Translational Research (VP DTR), will be a key leader in pioneering novel therapeutics and moving them from discovery, thru translation, and into clinical development.  The VP DTR will lead and manage a team of clinical directors and discovery scientists whose function is to map disease area biology, identify mechanisms of action, screen and refine lead candidates and then the operational implementation of translating into clinical activities to advance Company’ prescription digital therapeutics through clinical trials and regulatory review.

This position will involve extensive coordination with internal staff at Pear including  edical Affairs, the Product team, Clinical Development, Clinical Operations, Regulatory Affairs and Quality Assurance. The VP of DTR will form a tight alliance with Clinical Development and Corporate Development to integrate resources, to lead operational activities between functions, to identify safe and effective therapeutics, achieve preliminary efficacy in translational studies, improve efficiency and minimize costs of execution while meeting timelines. The VP of Discovery and Translation will collaborate with Pear’s external partners on clinical programs.

Responsibilities:

  • Discovery and Translation, with a focus on screening, identifying leads, and designing novel therapeutics, often in combination with pharmacotherapy and translating into clinical studies
  • Design and conduct translational clinical trials, in collaboration with the Clinical Operations Team
  • Collaborate on Proof-of-Concept (Phase 2-equivalent) Clinical Trials with the Clinical Development team
  • You will be responsible for the team and ultimate results of planning, design and execution of Discovery and Translational activities, including disease area and biology mapping, mechanism of action screening, embodiment, translation and preliminary efficacy into the clinic
  • Studies will be conducted utilizing Pear’s Clinical Operations team and Pear’s partners
  • Continuing to optimize Pear’s Discovery and Translational process
  • Manage the Clinical Directors and Discovery team, responsible for each of Pear’s Pipeline Programs
  • Collaborate with Clinical Development and other relevant stakeholders, internal and external, on abstract, posters, and publications
  • Support Corporate Development on Portfolio and Disease Area Strategy
  • As appropriate, conduct Investigator meetings, Clinical/Scientific Advisory Boards and Key Opinion Leaders with Clinical Development

Requirements/ Skills

  • An MD, PhD, or MD/PhD is required
  • 5+ years of relevant industry experience
  • Demonstrated expertise in Discovery, candidate production, screening, lead identification and advancement. Experience in Translational Clinical Studies in humans (as well as animals) preferred
  • CNS experience is highly desired
  • Experience with pharmacotherapy and neurobehavioral interventions is a plus
  • Experience planning, designing and conductiing FDA grade clinical trials
  • Strong familiarity with good clinical practices (GCP) and International Conference on Harmonization Guidelines
  • Ability to maintain a professional relationship with therapeutic area opinion leaders worldwide, and is equally comfortable discussing the science and research approaches that are critical for study protocol design, clinical endpoints and data interpretation
  • Residency and clinical practice experience strongly preferred
  • Working knowledge of FDA, EMA, PMDA regulations and expectations, Good Clinical Practice, ICH guidelines, and clinical development. Demonstrate experience in clinical design and implementation of Phase 1 to Phase 2 Proof-of-Concept Clinical studies, with direct leadership of trials that meet the timelines, budget, expected outcomes and lead to regulatory success of innovative medicines
  • Experience with digital interventions, evaluating software in studies, and/or sensors is highly desired
  • Strong leadership skills with a demonstrated ability to drive programs from conception through early development process in a pharmaceutical biotech setting
  • Excellent written and oral communication skills with the ability to effectively communicate cross-functionally and drive progress of multidisciplinary team
 
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Job ID: 581078

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